CERVIDIL

CERVIDIL- dinoprostone insert
Ferring Pharmaceuticals Inc.

1 INDICATIONS AND USAGE

CERVIDIL is indicated for the initiation and/or continuation of cervical ripening in pregnant women at or near term in whom there is a medical or obstetrical indication for the induction of labor.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage Instructions

Administer one CERVIDIL insert (10 mg) intravaginally for use up to 12 hours (approximately 0.3 mg of dinoprostone is released per hour) [see Dosage and Administration (2.2)].

Monitor uterine activity, fetal status, and the progression of cervical dilatation and effacement with the use of CERVIDIL. Remove CERVIDIL 12 hours after insertion with the onset of active labor, prior to an amniotomy, occurrence of uterine tachysystole, uterine hypersystole/hypertonicity, or fetal distress [see Warnings and Precautions (5.4)]. Remove CERVIDIL at least 30 minutes prior to administering an oxytocic agent [see Warnings and Precautions (5.4) and Drug Interactions (7)].

2.2 Preparation and Administration Instructions

CERVIDIL should be administered only by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities.

Preparation and Administration Instructions

  • Keep CERVIDIL frozen until ready for use. Do not warm CERVIDIL prior to vaginal insertion.
  • Tear open the individually-wrapped foil package containing CERVIDIL along the tear mark. Never open the package using scissors or other sharp objects because this may damage the knitted polyester retrieval system. Do not cut the retrieval system and do not use CERVIDIL unless its retrieval system is intact.
  • Immediately after opening the package, insert CERVIDIL transversely, in the posterior fornix of the vagina (see Figure 1). If necessary, use a minimal amount of water-miscible lubricant to assist vaginal insertion. Do not permit excess contact or coating with the lubricant, as this could prevent release of dinoprostone from the vaginal insert. Insertion does not require sterile conditions.
    Figure 1: Placement of CERVIDIL in the Posterior Vaginal FornixFigure 1
  • Tuck some of the excess retrieval system into the vagina to avoid movement of CERVIDIL away from the proper position; however, leave a small amount of the retrieval system outside the vagina to aid in retrieval.
  • Instruct women to remain in a recumbent position during insertion of CERVIDIL and for 2 hours afterward. Women may be ambulatory 2 hours after insertion; however, ensure that the insert remains in place.
Figure 1

2.3 Removal Instructions

  • To retrieve, locate the retrieval system and pull it gently until CERVIDIL is fully removed.
  • Upon removal of CERVIDIL, it is essential to perform a visual inspection to ensure that the slab has been removed, as it will continue delivering the active ingredient.

3 DOSAGE FORMS AND STRENGTHS

Vaginal Insert: 10 mg of dinoprostone (release rate approximately 0.3 mg/hour up to 12 hours) in a hydrogel polymer. The insert is beige-colored, semi-opaque, thin, flat, and rectangular in shape with rounded corners, measuring 29 mm by 9.5 mm by 0.8 mm, contained within an off-white knitted polyester pouch retrieval system (see Figure 2).

Figure 2: CERVIDIL Components
Figure 2
(click image for full-size original)

4 CONTRAINDICATIONS

CERVIDIL is contraindicated in patients with:

  • Known hypersensitivity to prostaglandins [see Adverse Reactions (6.2)]
  • Evidence or clinical suspicion of fetal distress where delivery is not imminent
  • Unexplained vaginal bleeding in the current pregnancy
  • Evidence or clinical suspicion of marked cephalopelvic disproportion
  • Conditions for which induction of labor is contraindicated
  • Conditions for which oxytocic drugs are contraindicated
  • Previous cesarean section or other uterine surgery expected to affect uterine integrity (such as myomectomy)
  • Conditions under which prolonged contraction of the uterus may be detrimental to fetal safety
  • Concurrent use with intravenous oxytocic agents [see Warnings and Precautions (5.4) and Drug Interactions (7)]
  • Six or more previous term pregnancies

5 WARNINGS AND PRECAUTIONS

5.1 For Hospital Use Only

CERVIDIL should be administered in a hospital setting with an obstetrical care facility.

5.2 Disseminated Intravascular Coagulation

CERVIDIL should be used with caution in women at high risk of postpartum disseminated intravascular coagulation (DIC). Physiologic or pharmacologic induction of labor, including the use of CERVIDIL, is associated with an increased risk of DIC during the postpartum period. Women aged 30 years or older, those with complications during pregnancy and those with a gestational age over 40 weeks have an increased risk of DIC during the postpartum period. As soon as possible, assess for an evolving fibrinolysis in the immediate post-partum period. Therapy consisting of prompt removal of the source of procoagulant material, replacement of depleted clotting factors and, in some cases, anti-coagulation with heparin should be instituted promptly.

5.3 Amniotic Fluid Embolism Syndrome

The use of dinoprostone-containing products, including CERVIDIL, can result in inadvertent disruption and subsequent embolization of antigenic tissue causing the development of Amniotic Fluid Embolism Syndrome, a rare and often fatal obstetric condition.

Carefully monitor patients for clinical signs of Amniotic Fluid Embolism Syndrome including hypotension, hypoxemia and respiratory failure, DIC, coma or seizures and provide supportive care as needed.

5.4 Uterine Tachysystole and Uterine Hypersystole/Hypertonicity

The use of CERVIDIL may cause uterine tachysystole with or without fetal heart rate changes (see Table 1). While using CERVIDIL, carefully monitor uterine activity, fetal status and the progression of cervical dilatation and effacement. Remove CERVIDIL with any evidence of uterine tachysystole, uterine hypersystole/hypertonicity, fetal distress, or if labor commences. CERVIDIL is contraindicated when prolonged contraction of the uterus is detrimental to fetal safety or uterine integrity, such as previous cesarean section or major uterine surgery, because of the risk of uterine rupture and obstetrical complications (e.g., need for hysterectomy and the occurrence of fetal or neonatal death). Prostaglandins, including CERVIDIL, may potentiate the effect of oxytocin [see Drug Interactions (7)]. Remove CERVIDIL at least 30 minutes before administration of an oxytocic agent is initiated and continue to carefully monitor uterine activity. Remove CERVIDIL prior to amniotomy or following rupture of membranes because the higher vaginal pH that occurs with rupture of membranes may result in higher release rate of dinoprostone.

5.5 Glaucoma

Prostaglandins, including CERVIDIL, can lead to raised intraocular pressure and constriction of pupils. Consider non-prostaglandin cervical ripening procedures in patients with Glaucoma.

6 ADVERSE REACTIONS

The following adverse reactions are described, or described in greater detail, in other sections:

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In placebo-controlled trials of 658 pregnant women (320 CERVIDIL-treated women and 338 placebo-treated women), the following treatment related adverse reactions (see Table 1) occurred at an incidence greater than 2% (and greater than that reported in the placebo group) in the CERVIDIL group [see Clinical Studies (14)].

Table 1. Common Adverse Reactions (≥ 2%) in Pregnant Patients Near Term Gestation in Trial 1*, Trial 2*, and Trial 3
*
Trial 1 (101-103) and Trial 2 (101-003) evaluated the dinoprostone insert only, without the use of a retrieval system
Trial 3 (101-801) evaluated the dinoprostone insert with the retrieval system.
Trials 1*and 2 *
CERVIDIL (N=320) Placebo (N=338)
Uterine tachysystole with fetal distress 2.8% 0.3%
Uterine tachysystole without fetal distress 4.7% 0%
Fetal distress without uterine tachysystole – 3.8% 1.2%
Trial 3
CERVIDIL (N=102) Placebo (N=104)
Uterine tachysystole with fetal distress 2.9% 0%
Uterine tachysystole -without fetal distress 2% 0%
Fetal distress without uterine tachysystole 2.9% 1%

Drug related fever, nausea, vomiting, diarrhea, and abdominal pain occurred in less than 1% of CERVIDIL-treated patients.

In Trial 3 (with the retrieval system) cases of tachysystole uterine hyperstimulation reversed within 2 to 13 minutes of removal of CERVIDIL. Tocolytics were required in one of the five cases.

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